Tussionex Pennkinetic extended-release suspension is used for:

Treating symptoms of the common cold, flu, or hayfever and other upper respiratory allergies such as cough, runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. It may also be used for other conditions as determined by your doctor.

Tussionex Pennkinetic extended-release suspension is a narcotic antitussive (cough suppressant) and antihistamine combination. The antitussive works by suppressing the cough center in the brain. The antihistamine works by blocking the action of histamine, which reduces the symptoms of an allergic reaction such as itch, watery eyes and runny nose.

Do NOT use Tussionex Pennkinetic extended-release suspension if:

you are allergic to any ingredient in Tussionex Pennkinetic extended-release suspension

you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tussionex Pennkinetic extended-release suspension:

Some medical conditions may interact with Tussionex Pennkinetic extended-release suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other codeine- or morphine-related medicine (eg, hydromorphone, oxycodone)

if you have a history of stomach or bowel problems (eg, inflammation, pseudomembranous colitis); chronic constipation; a blockage of your stomach, bladder, or bowel; gallbladder problems; difficulty urinating; or an enlarged prostate gland or other prostate problems

if you drink alcohol or you have a history of alcohol or substance abuse, mental or mood problems (eg, depression), or suicidal thoughts or behavior

if you have had recent surgery or plan to have surgery

if you are in poor health or are very overweight

Some MEDICINES MAY INTERACT with Tussionex Pennkinetic extended-release suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cimetidine or sodium oxybate (GHB) because the risk of severe drowsiness and breathing problems may be increased

Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) or tricyclic antidepressants (eg, imipramine) because the risk of their side effects or Tussionex Pennkinetic extended-release suspension's side effects may be increased

Buprenorphine, naloxone, or naltrexone because they may decrease Tussionex Pennkinetic extended-release suspension's effectiveness or withdrawal symptoms may occur in patients who have become physically dependent on opioids

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tussionex Pennkinetic extended-release suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tussionex Pennkinetic extended-release suspension:

Use Tussionex Pennkinetic extended-release suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Tussionex Pennkinetic extended-release suspension. Talk to your pharmacist if you have questions about this information.

Take Tussionex Pennkinetic extended-release suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Shake well before each use.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

Do NOT mix Tussionex Pennkinetic extended-release suspension with other fluids or medicines. Doing so may change how Tussionex Pennkinetic extended-release suspension works.

If you miss a dose of Tussionex Pennkinetic extended-release suspension and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tussionex Pennkinetic extended-release suspension.

Important safety information:

Tussionex Pennkinetic extended-release suspension may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tussionex Pennkinetic extended-release suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol while you are using Tussionex Pennkinetic extended-release suspension.

Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tussionex Pennkinetic extended-release suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

If your symptoms do not get better within 7 days or if you develop a high fever or persistent headache, check with your doctor.

Tell your doctor or dentist that you take Tussionex Pennkinetic extended-release suspension before you receive any medical or dental care, emergency care, or surgery.

The risk of severe breathing problems may be greater if you take Tussionex Pennkinetic extended-release suspension in high doses. Do NOT take more than the recommended dose without checking with your doctor.

Tussionex Pennkinetic extended-release suspension has cough suppressant and antihistamine in it. Before you start any new medicine, check the label to see if it has cough suppressant and antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Use Tussionex Pennkinetic extended-release suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems and drowsiness.

Caution is advised when using Tussionex Pennkinetic extended-release suspension in CHILDREN, especially those with lung or breathing problems (eg, croup); they may be more sensitive to its effects.

Tussionex Pennkinetic extended-release suspension should not be used in CHILDREN younger than 6 years old; they may be more sensitive to serious and even life-threatening breathing problems from Tussionex Pennkinetic extended-release suspension.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tussionex Pennkinetic extended-release suspension while you are pregnant. It is not known if Tussionex Pennkinetic extended-release suspension is found in breast milk. Do not breast-feed while taking Tussionex Pennkinetic extended-release suspension.

When used for long periods of time or at high doses, Tussionex Pennkinetic extended-release suspension may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Tussionex Pennkinetic extended-release suspension stops working well. Do not take more than prescribed.

Some people who use Tussionex Pennkinetic extended-release suspension for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness where pain relief is more important. If using Tussionex Pennkinetic extended-release suspension for an extended period of time, do not suddenly stop taking Tussionex Pennkinetic extended-release suspension without your doctor's approval. If you suddenly stop taking Tussionex Pennkinetic extended-release suspension, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping this medication.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Store Tussionex Pennkinetic extended-release suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tussionex Pennkinetic extended-release suspension out of the reach of children and away from pets.

General information:

If you have any questions about Tussionex Pennkinetic extended-release suspension, please talk with your doctor, pharmacist, or other health care provider.

Tussionex Pennkinetic extended-release suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Tussionex Pennkinetic extended-release suspension or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tussionex Pennkinetic extended-release suspension. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tussionex Pennkinetic extended-release suspension. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Tussionex Pennkinetic extended-release suspension.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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